ISO 22000 Resource Center: ISO 22000: WHAT IS ISO 22000 GAP ANALYSIS?

Gap Analysis VII

People are entitled to expect that the food they eat is wholesome and safe for consumption, food-borne disease is at best unpleasant; at worst it can be fatal. In considering market to consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer. In considering industry to market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues as well as policies on biotechnology and food with guidelines for management of governmental import and export inspection and certification systems for foods.

As a consequence, the food safety management systems begin to evolve, one of the most early systems were sample checking which was not adequate where HACCP came in to play a major role. But plant sanitation and infrastructure was playing a critical role where Good Manufacturing practices were became mandatory to run the HACCP which was explained as prerequisite programs. These principles were integrated into many food safety management systems which complex the scenario where various customers required different certifications. Considering all these issues International Organization for Standardization introduced the ISO 22000 in 2005. The ISO 22000 has integrated GMP, HACCP and ISO 9001 as its basis for the approach. ISO 22000 is a standard developed by the International Organization for Standardization dealing with food safety. This is a general derivative of ISO 9000. ISO 22000 standard: The ISO 22000 international standard specifies the requirements for a food safety management system that involves interactive communication, system management, prerequisite programs (PRP) and HACCP principles.

When the ISO 22000 standard is considered, it has specifically mentioned on the PRPs and Operational PRPs, because there were little confusions in the selection of PRPs while operating early HACCP systems where ISO 22000 has provided clear separation of these sectors. In order to achieve food safety, PRPs play a major role where personnel hygiene can be considered one of the main critical areas due to the greater possibilities of cross contamination. Thus ISO 22000 FSMS required more comprehensive implementation of personnel hygiene practices where ISO 22000 Gap Analysis is focus to find out almost all areas consider in the GMP and codex requirements which will be more beneficial while implementing ISO 22000 FSMS in your plant.

Section VII: Personnel Hygiene

7.1 General including training (GMP and Codex Requirement)

All employees should be informed in writing of their legal obligations and the company’s policy on personal hygiene prior to commencing work, with periodic updates as necessary. It is recommended that a standard induction course explaining the relevant legislation is designed and used by all QA managers for new staff.

It is recommended that all personnel be appropriately trained in food hygiene disciplines, relevant to the job they do. This training should encompass the requirements of personal hygiene, the reasons why they are so important and an explanation that they are a requirement.

Additionally ‘on the job’ training should be given to staff in order that they fully understand their responsibilities and the need to follow written instructions and procedures.

All Production and Quality Assurance personnel must be fully trained in the principles of Good Manufacturing Practice and comprehend the tasks assigned to them. All other personnel, including engineers, service and cleaning staff whose duties take them into the factory should also receive appropriate training.

Training records should be kept on each individual member of staff and the effectiveness of training monitored to confirm that designated procedures are being followed.

In the event of termination of employment, due consideration should be given to potential risk to the product and demonstrations of other operatives. Having earlier defined the employees legal obligations, any appropriate precaution should be taken as necessary

Adequate lockers must be provided for all personnel for the safe storage of personnel effects such as outdoor clothing, bags, etc. This will eliminate the risk of them being brought into production areas (which is forbidden). Lockers should be easily cleaned and, if possible, designed with a sloping top to prevent dust harbourage and use as a shelf.

A separate canteen or rest room area must be provided for operatives to take their meals and breaks.

Refreshments must not be taken into production areas. It is recommended that overalls be removed prior to using these areas.

Canteen facilities, particularly the food preparation areas must be of good design, have adequate storage and chilling facilities and be well run and maintained by appropriate staff.

Automatic drink dispensers can be acceptable, provided that they are suitably located, adequately cleaned and maintained. Disposal facilities for non-breakable empty drinking containers must be provided. Plastic beakers or cups must not be taken away from the vicinity of the drinks dispenser.

Rest areas must be kept in good decorative order, properly maintained and cleaned, and should provide adequate seating facilities to meet the maximum usage.

In high risk processes or sensitive environments, separate facilities may be required for different groups of operatives.

All toilets must be adequately lit and ventilated and separated from production areas by an ante-room supplied with hand washing facilities.

Toilet areas must be of good hygienic design and the floors, walls, ceiling and sanitary equipment must be clean and in good decorative order.

Adequate changing facilities must be provided for operatives to facilitate changing into protective clothing prior to entering the processing areas.

Separate storage must be provided for outdoor clothes and foot wear and the storage of protective clothing to prevent the risk of cross contamination.

6.2 Health Status (GMP and Codex Requirement)

People known, or suspected, to be suffering from, or to be a carrier of a disease or illness likely to be transmitted through food, should not be allowed to enter any food handling area if there is a likelihood of their contaminating food. Any person so affected should immediately report illness or symptoms of illness to the management.

Medical examination of a food handler should be carried out if clinically or epidemiologically indicated.

Compliance Criteria

Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically.

The Control Points

All company employees must be required to complete an appropriate examination and medical questionnaire, prior to commencing work. This applies to production/quality assurance staff, management, engineers, cleaners, office staff and any other permanent/temporary, full time or part time staff.
Persons directly involved in food processing or packing should be fit and capable of discharging their duties effectively.
Persons suffering from any infectious illness (particularly gastro-intestinal disorders, vomiting, diarrhea etc...) must not be permitted to work in contact with food or other food handlers. Additionally, operatives with skin infections, nasal or ear disorders should not be allowed to handle open food.
Any person suffering from infectious illness must be declared medically fit by their doctor before being allowed to return to work. Full records must be kept for each individual case.
On returning from holidays all employees must report any food poisoning symptoms they have had during their holiday and must be medically screened by a doctor prior to returning to work. Screening should include the faecal testing for pathogenic, food poisoning bacteria e.g. Salmonella, Staphylococcus aureus, etc.
Bi-annual medical for all employees should be undertaken by the company to ensure that operatives are healthy and capable of discharging their duties efficiently.

6.3 Illness and Injuries (GMP and Codex Requirement)

Conditions which should be reported to management, where any need for medical examination and/or possible exclusion from food handling can be considered includes:

Jaundice;

Diarrhoea;

Vomiting;

Fever;

Sore throat with fever;

Visibly infected skin lesions (boils, cuts, etc.);

Discharges from the ear, eye or nose;

Compliance Criteria

The Control Points

No person having untreated sores, cuts or grazes should be allowed to work in contact with foods. All such injuries must be reported and suitably treated (by a trained nurse or first aider).
Currently all cuts/ abrasions and sores on the hands are covered with a plaster and the hand covered with disposable glove. It is recommended that all cuts, sores or abrasions on the skin must be covered, after treatment, with a conspicuously coloured (blue) waterproof dressing. Such dressings must be accounted for at the end of each shift, and must be renewed before the start of each shift. It is preferable that such persons affected should not work on open food.
The company must provide the services of a fully trained nurse or first aider and a medical room with adequate equipment for the first aid treatment of illness or injury.
First aid equipment must be kept securely and issued only by trained staff.
All treatments must be fully recorded in the medical record book provided, with the patient’s name, date, disease and the medical supplies issued.

6.4 Personal Cleanliness (GMP and Codex Requirement)

Food handlers should maintain a high degree of personal cleanliness and, where appropriate, wear suitable protective clothing, head covering, and footwear. Cuts and wounds, where personnel are permitted to continue working, should be covered by suitable waterproof dressings.

Personnel should always wash their hands when personal cleanliness may affect food safety, for example:

At the start of food handling activities;

Immediately after using the toilet; and

After handling raw food or any contaminated material, where this could result in contamination of other food items; they should avoid handling ready-to-eat food, where appropriate.

Compliance Criteria

The Control Points

All operatives must enter the factory by a specific entrance, to a dedicated changing area where showering, hand washing and toilet facilities are available, and where outer garments are exchanged for work wear.
People from raw areas should not be allowed in the cooked product area and people from the cooked area should not enter raw product area. Separate lavoratories, frocks, boots, gloves, should be provided.
At the entrances to process areas, personnel should be guided to hand wash stations using appropriate means e.g use of guard rails, guard rail supervisor.
Hand-washing facilities must be suitably trapped and plumbed directly to drains. Design of wash basins and plumbing. Plumbing of hand-wash facilities directly to drains with suitable traps. This should lead directly into the drain and not allow splash, spillage or standing pools of liquid to form
Movement between different areas of the factory must be minimized, and constantly monitored by management. Recommended that the use of process areas as corridors from one area to another should be controlled.
To reduce the risk of cross contamination, boot washing facilities of adequate size and capacity shall be provided at entry points to processing areas and at transfer points between dirty and clean areas. Transfer of operatives across these boundaries limited.
The numbers and capacities of the facilities will be calculated according to the total No. of employee and the scope of production.
All food handling operatives and persons, who enter production areas for any reason, must be provided with clean protective clothing which must be worn at all times. This includes engineers, management and other casual visitors.
It is recommended that protective clothing be free of loose fastenings, such as buttons, and top pockets.
Any internal pockets provided in the garment must be at hip level. When deciding which style to adopt, attention should be given to how staff will dress and undress.
Boiler suits are not recommended for use in food production areas since during the changing regime, a large proportion falls onto the floor creating a potential contamination

risk.
Items of personal clothing (such as body warmers) must not be worn over protective clothing, and undergarments must not protrude below sleeves and cuffs.
Protective foot wear must be provided and a suitable facility to clean it.
Unless authorized, protective clothing and designated foot wear must not be worn by staff outside the factory, going to or from work or taking breaks outside, (exceptions: forklift truck drivers and external process workers ). Additionally, staff must not be allowed to take protective clothing from the premises.
Where ear plugs or ear muffs are provided because of production noise levels, all such issues must be accounted for at the end of each shift.
It is a management responsibility to ensure that an adequate supply of laundered protective clothing is available, and that the laundry standards are high. Fraying edges and tears must be professionally repaired, or the garment replaced to minimize the potential foreign body risk.
The changing frequency of newly laundered work wear will ultimately be dependent on the type of products being manufactured. A twice-weekly change of overalls/hats is recommended unless the job in hand is a particularly dirty operation, when a more frequent change will be needed.
Colour coding of protective work wear is essential in high risk or multi-disciplinary sites, to identify operatives and to ensure correct changing regimes. Additionally, service operatives with a specific role e.g. engineers, cleaners, distribution personnel, should be easily recognizable.
Where the services of a contract laundry are commissioned their premises must be vetted to ensure that standards are acceptable, and that cross contamination of cleaned overalls is not possible. Adequate separation of food handlers protective clothing from other contracts (e.g. hospitals or pharmaceutical industries) must be in place. Indeed, laundries with specific food processing units should be sought.
The hygienic transfer of overalls from laundry to food premises by distribution vehicles is

essential.
Provision must be made to protect the overalls from contamination and the vehicles must be suitably cleaned. ‘Shrouding’ of high risk overalls in plastic film sleeves is very advantageous to ensure clean handling practices prior to use.
Provision must be made to ensure that hands are kept clean and washed at frequent intervals, preferably in ‘warm’ water, using a non-perfumed bactericidal soap. Hands should be thoroughly dried, nails kept short and well manicured and cleaned by using a nailbrush. Where appropriate, non-perfumed barrier creams or alcohol based skin sanitizers should be provided.
Hands must be washed:-

immediately before putting on protective clothing, particularly important in the case of high risk;
Personnel;
Immediately before commencing work, or entering production areas;
After handling debris, refuse or food waste;
If they become soiled or visibly contaminated;
After visiting the toilet;
After blowing the nose or touching the mouth;

Sufficient hand-wash stations must be provided in toilet areas and at each entrance to the production area for the number of staff employed on site.
To ensure good hand washing disciplines, operatives should be channeled past the hand-wash stations by the use of guardrails or other appropriate measures.
Similar hand washing facilities should be provided at designated places within the food processing area to encourage good personal hygiene disciplines.
“Hands free” knee, elbow or electronically operated sink units are required, with a good supply of potable running water. Hand operated taps and ceramic sinks should be avoided because of their potential contamination risk.
Adequate drying facilities must be provided e.g disposable paper towels. Open bins or foot operated lidded bins must be provided at all hand-wash facilities for the disposal of sanitary waste.
Hand-wash sinks and drying facilities must not be used for utensil or general cleaning purposes.
Notices reminding staff of the hand washing requirements must be posted in each toilet, and by the urinal area, in break/canteen areas, at the hand wash sinks, and on every entrance door to the production areas.
The effectiveness of the hand washing disciplines should be monitored by the random implementation of hand swabs or contact plates. Suitable growth medium for Total Viable counts, Coli form counts and Staphylococcus aureus must be readily prepared and the swabs transferred as quickly as possible. For demonstration purposes during food hygiene training, swabs should be taken before and after the hand washing regime.
Where it is company policy to adopt the use of disposable colour coded gloves, in production areas, these gloves must be treated as a ‘second skin’, and regularly washed and changed. If they become damaged or torn, they must be removed because of the potential foreign body hazard.
Operatives should remove their overalls prior to using the toilet.

6.5 Personal behaviour (GMP and Codex requirement)

People engaged in food handling activities should refrain from behaviour which could result in contamination of food, for example:

Smoking;

Spiting;

Chewing or eating;

Sneezing or coughing over unprotected food;

Personal effects such as jewellery, watches, pins or other items should not be worn or brought into food handling areas if they pose a threat to the safety and suitability of food.

Compliance Criteria

The Control Points

Suitable hair retaining wear, must be worn by all personnel in open food areas, including production staff, engineers, management and other casual site visitors.
Whatever style of hat is chosen, it is best, especially for long hair, if hairnets are used first. These should be brightly coloured, not brown, so that they can be easily seen. Blue is usually the colour chosen because it is not a food colour.
The headwear provided must retain all hair, however, hairgrips or metal clips to hold headgear in position must not be allowed. Headwear must be of generous size and comfortable.
Personnel working in, or entering food processing or packing areas must not wear any jewellery. Wrist watches, ear rings, necklaces and bangles are not permissible.
Nail varnish must not be worn since it presents a potential foreign body risk to the product and strong perfumes are not allowed because of the possibility of taint.
It is essential that management set a good example and also abide by these personal hygiene requirements.
Smoking and the use of tobacco must only be allowed in properly designated areas e.g. canteen, rest rooms and offices. It is not permitted in production areas or toilets. Smoking utensils must not be carried in pockets in production areas. Facilities for the disposal of smoking materials must be provided at exits from smoking areas.
The company may decide at its own discretion, to make the whole production site a “No Smoking” zone.
This is perfectly acceptable but new employees should be informed at recruitment and established staff notified of the company’s decision in writing. This would then be incorporated into the Code of Practice for Personal Hygiene.
Eating and drinking must only be allowed in properly designated areas. Eating sweets, chewing gum or other food stuffs must be strictly forbidden in all production areas and toilet facilities.
Operatives must not be allowed to take their breaks or meals outside the building, without first removing their protective clothing.
Where canteen and rest room facilities are being shared, between high and low risk operatives, all operatives must remove protective clothing before entering the area.

6.6 Visitors (GMP and Codex Requirement)

Visitors to food manufacturing, processing or handling areas should, where appropriate, wear protective clothing and adhere to the other personal hygiene provisions in this section.

Compliance Criteria

The Control Points

There must be adequate screening of all visitors to the factory must occur. On arrival, they must report to reception, sign the visitor’s book and complete a detailed questionnaire. The information required should include:-

Name, company, date of visit, who visiting;
Purpose of visit (which departments, individual);
Other food premises visited within previous 72 hours (high risk factories only);
Whether they have been stool tested for salmonella (high risk factories only);
If they have recently be abroad, if so where?

If the information provided gives cause for alarm, then following further investigation, accesses to the factory should be declined, and an alternative appointment made.

ISO 22000 Resource Center

Monday, March 17, 2014

ISO 22000: WHAT IS ISO 22000 GAP ANALYSIS? – Section VII

1 comment: